Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06347393 |
| Other study ID # |
6425 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
March 31, 2026 |
Study information
| Verified date |
March 2024 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Anna D'Angelo, MD |
| Phone |
+390630158637 |
| Email |
anna.dangelo[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer
in transgender and gender-diverse population.
Description:
In recent years, the scientific community has been paying increasing attention to lesbian,
gay, bisexual, transgender, queer, intersexual, asexual population, with a special focus on
transgender and gender-diverse individuals. Globally, the percentage of adults who identify
themselves as transgender varies between 0.3% and 0.5%, while approximately 0.5% to 4.5% of
adults are estimated to identify as gender-diverse. Despite the growing visibility of
transgender and gender-diverse community and the efforts towards their depathologization,
healthcare still needs to address two fundamental issues: the inadequate preparation of
healthcare staff regarding gender incongruence which results in mistreatment and
discrimination and the lack of uniform and large-scale prospective data. Scientific evidence
regarding the risk of developing breast cancer (BC) in these patients and the related
benefits of BC screening are still limited and insufficient. The Associazione Italiana di
Oncologia Medica (AIOM), reported that the risk of developing BC tends to increase in
transgender women compared to cisgender men (standardized incidence ratio [SIR], 46.7; 95%
CI, 27.2-75.4), although it does not reach the level of risk in cisgender women (SIR, 0.3;
95% CI, 0.2-0.4). Conversely, in transgender men, the risk of BC decreases when compared to
cisgender women (SIR, 0.2; 95% CI, 0.1-0.5), but it still remains higher than the risk
present in cisgender men (58.9; 95% CI, 18.7-142.2).As for the screening programs, there is a
lower adherence among the transgender and non-conforming-gender population compared to the
cisgender population, due to socio-economic barriers and a lack of clear recommendations
supported by scientific evidence.The National Comprehensive Cancer Network (NCCN)and AIOM
guidelines currently do not include specific recommendations for transgender individuals due
to the aforementioned lack of scientific evidence.
The American College of Radiology (ACR) regulates screening protocols for the transgender
population based on factors such as age, hormone therapy exposure, surgical history, and risk
categories.
